Evaluation on the Safety of Ticagrelor Among Chinese ACS Patients

Acute Coronary Syndrome (ACS) Clinical Trial

— YingLong  

Official title:

A Multi-Centre, Prospective Cohort, Non-Interventional Study About Evaluation on the Safety of Ticagrelor Among Chinese ACS Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02430493
• Other study ID #: D5130R00026
• Status: Completed
• Phase: N/A
• First received: April 27, 2015
• Last updated: March 12, 2018
• Start date: May 28, 2015
• Est. completion date: March 29, 2017

Study information

• Verified date: March 2018
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The primary objective is to describe the safety and tolerability of ticagrelor, by assessment of adverse events (characteristics, reporting rate, severity, relationship and risk factors), especially the bleeding events as defined in 8.1 and other serious adverse events (SAEs) during 1-year follow up in Chinese acute coronary syndrome (ACS) patients.

Description:

The trial is a multi-centre, prospective cohort, non-interventional study to be conducted in the department of cardiology from approximately 20 tier-2 or 3 hospitals, China. The study requires Chinese subjects aged over 18, diagnosed as ACS and treated with ticagrelor at least one tablet from the department of cardiology in the around 20 tier-2 or 3 hospitals. The subjects will be tracked up to 1 month after the discontinuation of ticagrelor for AE events and 1 year after enrollment for major cardiovascular events. This is an observational study. The prescribing doctor is in charge of prescribing or discontinuation ticagrelor. The investigator in an observational study may not intervene in the treatment. All 1000 subjects' related data will be collected

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1066
• Est. completion date: March 29, 2017
• Est. primary completion date: March 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

Inclusion Criteria:

• 1. Provision of informed consent prior to any study specific procedures 2. Chinese female or male aged at least 18 years 3. Index event of non-ST or ST segment elevation ACS. 4. Taken with ticagrelor at least one tablet before enrollment.

Exclusion Criteria:

-1. Participation in another clinical study with an investigational product during the last 6 months.

2. Previous enrolment in the present study; 3. Allergy or any other contraindication to ticagrelor as described in ticagrelor China PI.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndrome (ACS)

Locations

Country	Name	City	State
China	Research Site	Beijing
China	Research Site	Changchun
China	Research Site	Changsha
China	Research Site	Dalian
China	Research Site	Guangzhou
China	Research Site	Huai'an
China	Research Site	Jinan
China	Research Site	Nanjing
China	Research Site	Shanghai
China	Research Site	Shenzhen
China	Research Site	Suqian
China	Research Site	Tai'an
China	Research Site	Wuhan
China	Research Site	Xuzhou
China	Research Site	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

References & Publications (3)

Li J, Li X, Wang Q, Hu S, Wang Y, Masoudi FA, Spertus JA, Krumholz HM, Jiang L; China PEACE Collaborative Group. ST-segment elevation myocardial infarction in China from 2001 to 2011 (the China PEACE-Retrospective Acute Myocardial Infarction Study): a retrospective analysis of hospital data. Lancet. 2015 Jan 31;385(9966):441-51. doi: 10.1016/S0140-6736(14)60921-1. Epub 2014 Jun 23. Retraction in: Lancet. 2015 Jan 31;385(9966):402. — View Citation

Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC), Steg PG, James SK, Atar D, Badano LP, Blömstrom-Lundqvist C, Borger MA, Di Mario C, Dickstein K, Ducrocq G, Fernandez-Aviles F, Gershlick AH, Giannuzzi P, Halvorsen S, Huber K, Juni P, Kastrati A, Knuuti J, Lenzen MJ, Mahaffey KW, Valgimigli M, van 't Hof A, Widimsky P, Zahger D. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2012 Oct;33(20):2569-619. doi: 10.1093/eurheartj/ehs215. Epub 2012 Aug 24. — View Citation

Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators, Freij A, Thorsén M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of ticagrelor, by assessment of adverse events, especially the bleeding events and other SAEs during 1-year follow up in Chinese ACS patients.	a) Incidence of post-authorization adverse events including characteristics, reporting rate, severity, relationship and risk factors among Chinese ACS patients with ticagrelor during 1-year follow up b) PLATO-defined fatal/life-threatening bleedings during 1-year follow up in Chinese ACS patients treated with ticagrelor. c) PLATO-defined major bleedings during 1-year follow up in Chinese ACS patients treated with ticagrelor. d) PLATO-defined major + minor bleedings during 1-year follow up in Chinese ACS patients treated with ticagrelor. e) PLATO-defined major + minor + minimal bleedings during 1-year follow up in Chinese ACS patients treated with ticagrelor. f) Serious adverse events other than bleeding during 1-year follow up in Chinese ACS patients treated with ticagrelor	1 year
Secondary	Incidence of major cardiovascular (CV) events during 1-year follow up in Chinese ACS patients treated with ticagrelor.	Major CV events including CV death, MI and Stroke, during 1 year follow up in Chinese ACS patients treated with ticagrelor. Incidence of post-authorization adverse events among specific patients groups from Chinese ACS patients with ticagrelor. Survival free of major CV events among Chinese ACS patients with ticagrelor. Proportion of patients with discontinuation or interruption of ticagrelor and the reasons.	1 year

External Links

•   D5130R00026 synopsis